Freeze dried combination of Lansoprazole available for linjection and preparation method

Abstract

The invention provides a lansoprazole freeze-dried composition available for injection and a preparation method thereof, which comprises lansoprazole as the main agent and adds auxiliary materials, and the components in parts by weight are: 30-60 parts of lansoprazole , 2-20 parts of auxiliary solvent, 5-50 parts of basic amino acid stabilizer, and 0.3-8.5 parts of water in auxiliary materials. It can prolong the time of lansoprazole precipitation and crystallization, and no crystallization occurs in the whole production process, so as to improve product quality, not reduce drug efficacy during use, reduce production cost, increase production batch, etc.

Description

technical field [0001] The invention relates to a proton pump inhibitor, which is an injectable freeze-dried composition mainly composed of lansoprazole and a preparation method thereof. Background technique [0002] Lansoprazole has been publicly used as a medicinal ingredient, and the common dosage forms are tablets, capsules, etc., and there are also very few freeze-dried powder injections. Because it adopts meglumine as the stabilizing agent in the freeze-dried powder component, and the structure of meglumine only contains a basic group, although there is a certain buffering power, it is not strong enough to make lansoprazole injection Precipitation and crystallization will occur within 4 hours of the prepared medicinal solution at room temperature. And the crystallization amount that lansoprazole occurs in the injection is one of the most important indicators of quality control in production. In production, from the coarse filtration of liquid preparation, the determin...

AI Technical Summary

Problems solved by technology

It can be seen from this that the use of meglumine as a stabilizer component results in less production batches, high production costs, and it is difficult to ensure product quality. Although high-precision filters can be used in injections to avoid harm to the human body, crystals Reduced dosage after being filtered makes the drug less effective